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An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of a Two-dose Regimen of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells (Using Photodynamic Treatment), in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

Trial Profile

An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of a Two-dose Regimen of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells (Using Photodynamic Treatment), in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs T cell replacement therapy TH 9402 (Primary)
  • Indications Graft-versus-host disease
  • Focus Therapeutic Use
  • Sponsors Kiadis Pharma
  • Most Recent Events

    • 06 Nov 2019 Results of pooled post-hoc analysis assesing overall survival by using data from three studies including this study released in the 61st Annual Meeting and Exposition of the American Society of Hematology.
    • 06 Nov 2019 According to a Kiadis Pharma media release, new ATIR101 data will be discussed in an oral presentation exploring the effect of a single infusion of ATIR101 on survival outcomes in patients with blood cancer who underwent T-cell depleted haploidentical-hematopoietic stem cell transplantation (haplo-HSCT) from a pooled analysis of two Phase II trials (CR-AIR-007, NCT01794299; CR-AIR-008, NCT02500550) at the 59th Annual Meeting of the American Society of Hematology (ASH).
    • 28 May 2019 This trial has been completed in Croatia, according to European Clinical Trials Database.
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